Department of Pathology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.
Department of Radiology, School of Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Curr Gene Ther. 2024;25(1):72-88. doi: 10.2174/0115665232283880240301035621.
Metastatic Triple-negative Breast Cancer (mTNBC) is the most aggressive form of breast cancer, with a greater risk of metastasis and recurrence. Research studies have published in-depth analyses of the advantages and disadvantages of pembrolizumab, and early data from numerous trials suggests that patients with mTNBC have had remarkable outcomes. This meta-analysis compares the data from numerous relevant studies in order to evaluate the safety and efficacy of pembrolizumab monotherapy or combination therapies for mTNBC.
To identify eligible RCTs, a thorough literature search was carried out using electronic databases. CMA software was utilized to perform heterogeneity tests using fixed and random-effects models.
According to our pooled data, the median Progression-free Survival (PFS) was 2.66 months, and the median overall survival (OS) was 12.26 months. Furthermore, by comparing efficacy indicators between PD-L1-positive and PD-L1-negative groups, a correlation was found between the overexpression of PD-L1 with OS, PFS, and ORR. Patients with PD-L1-positive tumors had a higher response rate, with an ORR of 21.1%, compared to the patients with PD-L1-negative tumors. The ORR for first-line immunotherapy was higher than that of ≥second-line immunotherapy. In addition, pembrolizumab plus combination treatment resulted in a pooled incidence of immune- related adverse events of 22.7%.
A modest response to pembrolizumab monotherapy was detected in the mTNBC patients. Furthermore, a better outcome from pembrolizumab treatment may be predicted by PD-L1-- positive status, non-liver/lung metastases, combination therapy, and first-line immunotherapy. Pembrolizumab, in combination with chemotherapy, may be more beneficial for patients whose tumors are PD-L1 positive.
转移性三阴性乳腺癌（mTNBC）是最具侵袭性的乳腺癌类型，具有更高的转移和复发风险。研究已经深入分析了帕博利珠单抗的优缺点，并且来自众多试验的早期数据表明，mTNBC 患者的结果显著。本荟萃分析比较了大量相关研究的数据，以评估帕博利珠单抗单药或联合治疗 mTNBC 的安全性和有效性。
为了确定合格的 RCT，我们使用电子数据库进行了全面的文献搜索。使用 CMA 软件通过固定和随机效应模型进行异质性检验。
根据我们的汇总数据，中位无进展生存期（PFS）为 2.66 个月，中位总生存期（OS）为 12.26 个月。此外，通过比较 PD-L1 阳性和 PD-L1 阴性组的疗效指标，发现 PD-L1 过表达与 OS、PFS 和 ORR 之间存在相关性。PD-L1 阳性肿瘤患者的反应率更高，ORR 为 21.1%，而 PD-L1 阴性肿瘤患者的 ORR 为 14.4%。一线免疫治疗的 ORR 高于≥二线免疫治疗。此外，帕博利珠单抗联合治疗导致免疫相关不良事件的总发生率为 22.7%。
在 mTNBC 患者中检测到帕博利珠单抗单药治疗的反应适度。此外，PD-L1 阳性状态、非肝/肺转移、联合治疗和一线免疫治疗可能预示着帕博利珠单抗治疗的更好结果。帕博利珠单抗联合化疗可能对 PD-L1 阳性肿瘤患者更有益。
